Grappler Suture Anchor SystemRecalls & reported problems across all models

We found 2 models of Grappler Suture Anchor System by Paragon 28, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2025 and Dec 1, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Grappler Suture Anchor System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 13, 2022Class IIOpen, Classified

   Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.

   Z-1776-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported Grappler Suture Anchor System problems

Grappler Suture Anchor System models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Grappler™ Suture Anchor System P44-110-3010-SK

  Fastener, fixation, nondegradable, soft tissue
  1 recall0 reports
• Grappler™ Suture Anchor System P44-210-0014-SK

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  2 reports

Recent Grappler Suture Anchor System adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE 2 INSTRUMENT FRACTURED, AND THE DEBRIS REMAINS IN THE PATIENT WITH NO KNOWN IMPACT OR CONSEQUENCE REPORTED AT THE TIME OF THE EVENT. NO ADDITIONAL PATIENT TREATMENT BEYOND INTRAOPERATIVE IMAGING AND RETRIEVAL ATTEMPTS WAS REPORTED. THERE WERE NO KNOWN COMPLICATIONS. THERE WAS AN INTRA-OPERATIVE DELAY OF LESS THAN APPROXIMATELY 30 MINUTES. THE PATIENT HAD RETAINED METAL FRAGMENTS WITH NO KNOWN SIDE EFFECTS, AND NO REVISION WAS REQUIRED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23682355 ↗
• InjuryDec 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE 2 INSTRUMENT FRACTURED, AND THE DEBRIS REMAINS IN THE PATIENT WITH NO KNOWN IMPACT OR CONSEQUENCE REPORTED AT THE TIME OF THE EVENT. NO ADDITIONAL PATIENT TREATMENT BEYOND INTRAOPERATIVE IMAGING AND RETRIEVAL ATTEMPTS WAS REPORTED. THERE WERE NO KNOWN COMPLICATIONS. THERE WAS AN INTRA-OPERATIVE DELAY OF LESS THAN APPROXIMATELY 30 MINUTES. THE PATIENT HAD RETAINED METAL FRAGMENTS WITH NO KNOWN SIDE EFFECTS, AND NO REVISION WAS REQUIRED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23682334 ↗

Other Paragon 28, Inc. products

• Phantom Hindfoot TTC/TC Nail System3 models · 5 reports · 2 recalls
• Baby Gorilla/Gorilla Plating System10 models · 18 reports · 1 recall
• Phantom Fibula Nail System2 models · 3 reports · 1 recall